Tokyo, Sept. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059003) titled 'Evaluation of the Effect of the Test Beverage on GLP-1 Secretion' on Sept. 5.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of a single intake of the test beverage on circulating GLP-1 secretion, and its effects on blood glucose, insulin, and subjective visual analogue scale (VAS) ratings.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - A single oral administration of Test Beverage 1
Interventions/Control_2 - A single oral administration of Test Beverage 2
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals who are able to undergo serial blood sampling.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals with HbA1c greater than or equal to 6.5%.
2. Individuals with a blood glucose level at 2 hours greater than or equal to 200 mg/dL during the pre-screening oral glucose tolerance test.
3. Individuals with a fasting blood glucose level greater than or equal to 126 mg/dL.
4. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims related to blood glucose which could affect the study, and who are unable to discontinue use from the time of consent acquisition.
5. Individuals who are taking medications that could affect the study, such as intestinal regulators or laxatives.
6. Individuals who have used for medications for disease treatment (excluding occasional use for headache, menstrual pain, common cold, etc.) within 1 month prior to consent acquisition.
7. Individuals use of any antibiotic-containing medications from 1 month prior to informed consent until the time of consent acquisition.
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with excessive alcohol intake.
10. Individuals on intentional dietary restriction.
11. Individuals with irregular lifestyle or eating habits (for example, shift work, night work), or those likely to have lifestyle changes during the study period
12. Individuals who have experienced a marked change in living environment affecting lifestyle within 1 month prior to informed consent (for example, moving residence, unemployment, divorce, death of a spouse or relative).
Target Size - 32
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 08 Month 18 Day
Date of IRB - 2025 Year 08 Month 15 Day
Anticipated trial start date - 2025 Year 09 Month 08 Day
Last follow-up date - 2025 Year 11 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066954
Disclaimer: Curated by HT Syndication.
